Drug intolerance to high-dose clarithromycin among elderly patients

doi:10.1016/0732-8893(93)90112-K

Diagnostic Microbiology and Infectious Disease

Volume 16, Issue 3, March–April 1993, Pages 215-221

https://doi.org/10.1016/0732-8893(93)90112-K Get rights and content

Abstract

We treated 13 elderly patients with chronic mycobacterial lung disease with clarithromycin using 1000mg b.i.d. as monotherapy. Patients had a mean age of 70 years, and 12 of 13 had creatinine clearances of 31–71 ml/min. Adverse events were seen in 100% of patients, with the most common being bitter taste (92%), nausea (92%), vomiting (54%) and central nervous system symptoms (54%). Elevated liver enzymes developed in five (38%) of 13 patients at weeks 1–6 of therapy. Mean serum levels of clarithromycin plus its 14-OH metabolite were 12.9 ± 3.6 μg/ml (SD). There were 11 patients (85%) who discontinued the high dose within 3 months because of side effects. Serum drug levels of clarithromycin plus its 14-OH metabolite consistently exceeded 12 μg/ml in six of six patients who discontinued drug (10 of 10 values) compared with neither of two patients who tolerated the high dose (0 of 6 values). A dose reduction to 500mg b.i.d. was well tolerated (nine of 10 patients). Future trials with clarithromycin in this population should use lower doses with attention to body mass and renal function to minimize side effects.

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^☆: This study was supported in part by a grant from Abbott Laboratories.

¹: The authors thank Kathleen Blahunka and Carl Craft for their assistance with the study, and Ken Tanaka for performance of the clarithromycin serum levels.

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Diagnostic Microbiology and Infectious Disease

Abstract

References (16)

Clarithromycin, a unique macrolide: a pharmacokinetic, microbiological and clinical overview

Diagn Microbiol Infect Dis

Azithromycin for treatment of Mycobacterium avium-intracellulare complex infection in patients with AIDS

Lancet

Prediction of creatinine clearance from serum creatinine

Nephron

Pharmacokinetics of clarithromycin in subjects with varying renal function

Activity of clarithromycin against Mycobacterium avium infection in AIDS patients: a controlled clinical trial

Am Rev Respir Dis

Clarithromycin-containing regimens in the treatment of 54 AIDS patients with disseminated Mycobacterium avium-intracellulare infection

Clarithromycin containing regimens for mycobacterial infections in 55 non AIDs patients

Am Rev Respir Dis

Clarithromycin-ciprofloxacin-amikacin for therapy of Mycobacterium avium-Mycobacterium intracellulare bacteremia in patients with AIDS

J Clin Microbiol

Cited by (107)

Hepatic Injury due to Drugs, Dietary and Herbal Supplements, Chemicals and Toxins

Tolerability, adverse events, and efficacy of treatment for Mycobacterium avium complex pulmonary disease in elderly patients

Delivering macrolide antibiotics to heal a broken heart – And other inflammatory conditions

Drugs and Toxins

Macrolides, Clindamycin, and Ketolides

Dosing errors in prescribed antibiotics for older persons with CKD: A retrospective time series analysis

Clinical studyDrug intolerance to high-dose clarithromycin among elderly patients☆

Abstract

Diagn Microbiol Infect Dis

Lancet

Prediction of creatinine clearance from serum creatinine

Nephron

Pharmacokinetics of clarithromycin in subjects with varying renal function

Activity of clarithromycin against Mycobacterium avium infection in AIDS patients: a controlled clinical trial

Am Rev Respir Dis

Clarithromycin-containing regimens in the treatment of 54 AIDS patients with disseminated Mycobacterium avium-intracellulare infection

Clarithromycin containing regimens for mycobacterial infections in 55 non AIDs patients

Am Rev Respir Dis

Clarithromycin-ciprofloxacin-amikacin for therapy of Mycobacterium avium-Mycobacterium intracellulare bacteremia in patients with AIDS

J Clin Microbiol

Clinical study
Drug intolerance to high-dose clarithromycin among elderly patients☆